Neoral

Neoral prevents organ rejection after a transplant. May increase your risk of getting an infection. Tell your doctor if you notice symptoms of an infection such as fever.

Neoral Overview

Updated: April 23, 2015

Neoral is a prescription medication used to prevent transplant rejection in those who have received kidney, liver, and heart transplants. Neoral may also be used to treat psoriasis and symptoms of rheumatoid arthritis. Neoral belongs to a group of drugs called immunosuppressants. They work by decreasing the activity of the immune system.

Neoral comes as a capsule and an oral liquid solution. It is usually taken twice a day. This medication is available as a modified form of cyclosporine that has been slightly changed to be more easily absorbed by the body.

Common side effects of Neoral include high blood pressure, gum overgrowth, and tremors.

Neoral Precautions

Neoral is available as a modified (changed) form of cyclosporine so that the medication can be better absorbed in the body. Original cyclosporine and cyclosporine (modified) are absorbed by the body in different amounts, so they cannot be substituted for one another. Take only the type of cyclosporine that was prescribed by your doctor. When your doctor gives you a written prescription, check to be sure that he or she has specified the type of cyclosporine you should receive. Each time you have your prescription filled, look at the brand name printed on your prescription label to be sure that you have received the same type of cyclosporine. Talk to your pharmacist if the brand name is unfamiliar or you are not sure you have received the right type of cyclosporine.

Taking Neoral may increase the risk that you will develop an infection or cancer, especially lymphoma (cancer of a part of the immune system) or skin cancer. This risk may be higher if you take Neoral with other medications that decrease the functioning of the immune system such as azathioprine (Imuran), cancer chemotherapy, methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf). Tell your doctor if you are taking any of these medications, and if you have or have ever had any type of cancer. To reduce your risk of skin cancer, plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen during your treatment. If you experience any of the following symptoms, call your doctor immediately:

sore throat

fever

chills and other signs of infection

flu-like symptoms

coughing

difficulty urinating

pain when urinating

a red, raised, or swollen area on the skin

new sores or discoloration on the skin

lumps or masses anywhere in your body

night sweats

swollen glands in the neck, armpits, or groin

trouble breathing

chest pain

weakness or tiredness that does not go away

pain, swelling, or fullness in the stomach

Neoral may cause high blood pressure and kidney damage. Tell your doctor if you have or have ever had high blood pressure or kidney disease. If you experience any of the following symptoms, call your doctor immediately:

dizziness

swelling of the arms, hands, feet, ankles, or lower legs

fast, shallow breathing

nausea

irregular heartbeat

If you have psoriasis, tell your doctor about all the psoriasis treatments and medications you are using or have used in the past. The risk that you will develop skin cancer is greater if you have ever been treated with PUVA (psoralen and UVA; treatment for psoriasis that combines an oral or topical medication with exposure to ultraviolet A light); methotrexate (Rheumatrex) or other medications that suppress the immune system; UVB (exposure to ultraviolet B light to treat psoriasis); coal tar; or radiation therapy. You should not be treated with PUVA, UVB, or medications that suppress the immune system while you are taking Neoral to treat psoriasis.

Neoral may cause growth of extra tissue in your gums. Be sure to brush your teeth carefully and see a dentist regularly during your treatment to decrease the risk that you will develop this side effect.

Tell your doctor if you are being treated with phototherapy (a treatment for psoriasis that involves exposing the skin to ultraviolet light) and if you have or have ever had low levels of cholesterol or magnesium.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to Neoral.

Neoral Food Interactions

Grapefruit and grapefruit juice may interact with Neoral and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Your doctor may tell you to limit the amount of potassium in your diet. Follow these instructions carefully. Talk to your doctor about the amount of potassium-rich foods such as bananas, prunes, raisins, and orange juice you may have in your diet. Many salt substitutes contain potassium, so talk to your doctor about using them during your treatment.

Inform MD

Before using Neoral, tell your doctor about all of your medical conditions including:

if you are allergic to Neoral, any other medications, or any of the inactive ingredients in Neoral. Ask your pharmacist for a list of the inactive ingredients

tell your doctor if you have or have ever had any of the conditions mentioned in the "Neoral Precautions" section

tell your doctor if you have low cholesterol, low levels of magnesium in your blood, any condition that makes it difficult for your body to absorb nutrients, or liver disease

tell your doctor if you have an eye infection, if you have a punctal plug (stopper inserted by a doctor in a tear duct to keep tears in the eye), and if you have or have ever had a herpes infection of the eye

if you are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Do not have vaccinations without talking to your doctor.

Neoral and Pregnancy

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Neoral falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Neoral and Lactation

Neoral Usage

Neoral comes as a capsule and a solution (liquid) to take by mouth. Neoral is usually taken twice a day. It is important to take Neoral on a regular schedule. Take Neoral at the same time(s) each day, and allow the same amount of time between doses and meals every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Neoral exactly as directed. Do not take more or less of the medication or take it more often than prescribed by your doctor.

You may notice an unusual smell when you open a blister card of Neoral capsules. This is normal and does not mean that the medication is damaged or unsafe to use.

Neoral oral solution may gel or become lumpy if it is exposed to temperatures below 68 °F (20 °C). You can use the solution even if it has gelled, or you can turn the solution back to a liquid by allowing it to warm to room temperature (77 °F [25 °C]).

Neoral oral solution must be mixed with a liquid before use. Neoral oral solution may be mixed with orange juice or apple juice but should not be mixed with milk. You should choose one drink from the appropriate list and always mix your medication with that drink.

To take either type of oral solution, follow these steps:

Fill a glass (not plastic) cup with the drink you have chosen.

Remove the protective cover from the top of the dosing syringe that came with your medication.

Place the tip of the syringe into the bottle of solution and pull back on the plunger to fill the syringe with the amount of solution your doctor has prescribed.

Hold the syringe over the liquid in your glass and press down on the plunger to place the medication in the glass.

Stir the mixture well.

Drink all of the liquid in the glass right away.

Pour a little more of the drink you have chosen into the glass, swirl the glass around to rinse, and drink the liquid.

Dry the outside of the syringe with a clean towel and replace the protective cover. Do not wash the syringe with water. If you do need to wash the syringe, be sure that it is completely dry before you use it to measure another dose.

Neoral FDA Warning

Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Neoral. At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Neoral. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Neoral, a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients Neoral may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients.

Neoral Soft Gelatin Capsules MODIFIED and Neoral Oral Solution MODIFIED have increased bioavailability in comparison to Sandimmune Soft Gelatin Capsules and Sandimmune Oral Solution. Neoral and Sandimmune are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with Neoral than with Sandimmune. If a patient who is receiving exceptionally high doses of Sandimmune is converted to Neoral, particular caution should be exercised. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis patients taking Neoral to avoid toxicity due to high concentrations. Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low concentrations. Comparison of blood concentrations in the published literature with blood concentrations obtained using current assays must be done with detailed knowledge of the assay methods employed.

Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking Neoral.

Cyclosporine, the active ingredient in Neoral, in recommended dosages, can cause systemic hypertension and nephrotoxicity. The risk increases with increasing dose and duration of cyclosporine therapy. Renal dysfunction, including structural kidney damage, is a potential consequence of cyclosporine, and therefore, renal function must be monitored during therapy.

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